Addressing missing outcome data in randomised controlled trials: A methodological scoping review.

BACKGROUND: Missing outcome data is common in trials, and robust methods to address this are needed. Most trial reports currently use methods applicable under a missing completely at random assumption (MCAR), although this strong assumption can often be inappropriate. OBJECTIVE: To identify and summarise current literature on the analytical methods for handling missing outcome data in randomised controlled trials (RCTs), emphasising methods appropriate for data missing at random (MAR) or missing not at random (MNAR). STUDY DESIGN AND SETTING: We conducted a methodological scoping review and identified papers through searching four databases (MEDLINE, Embase, CENTRAL, and CINAHL) from January 2015 to March 2023. We also performed forward and backward citation searching. Eligible papers discussed methods or frameworks for handling missing outcome data in RCTs or simulation studies with an RCT design. RESULTS: From 1878 records screened, our search identified 101 eligible papers. 90 (89%) papers described specific methods for addressing missing outcome data and 11 (11%) described frameworks for overall methodological approach. Of the 90 methods papers, 30 (33%) described methods under the MAR assumption, 48 (53%) explored methods under the MNAR assumption and 11 (12%) discussed methods under a hybrid of MAR and MNAR assumptions. Control-based methods under the MNAR assumption were the most common method explored, followed by multiple imputation under the MAR assumption. CONCLUSION: This review provides guidance on available analytic approaches for handling missing outcome data, particularly under the MNAR assumption. These findings may support trialists in using appropriate methods to address missing outcome data.

Using the Behaviour Change Wheel to identify barriers and targeted strategies to improve adherence in randomised clinical trials: The example of MEL-SELF trial of patient-led surveillance for melanoma.

BACKGROUND: Adherence to self-management interventions is critical in both clinical settings and trials to ensure maximal effectiveness. This study reports how the Behaviour Change Wheel may be used to assess barriers to self-management behaviours and develop strategies to maximise adherence in a trial setting (the MEL-SELF trial of patient-led melanoma surveillance). METHODS: The Behaviour Change Wheel was applied by (i) using the Capability, Opportunity, Motivation-Behaviour (COMB) model informed by empirical and review data to identify adherence barriers, (ii) mapping identified barriers to corresponding intervention functions, and (iii) identifying appropriate behaviour change techniques and developing potential solutions using the APEASE (Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Side-effects and safety, Equity) criteria. RESULTS: The target adherence behaviour was defined as conducting a thorough skin self-examination and submitting images for teledermatology review. Key barriers identified included: non-engaged skin check partners, inadequate planning, time constraints, low self-efficacy, and technological difficulties. Participants' motivation was positively influenced by perceived health benefits and negatively impacted by emotional states such as anxiety and depression. We identified the following feasible interventions to support adherence: education, training, environmental restructuring, enablement, persuasion, and incentivisation. Proposed solutions included action planning, calendar scheduling, alternative dermatoscopes, optimised communication, educational resources in various formats to boost self-efficacy and motivation and optimised reminders (which will be evaluated in a Study Within A Trial (SWAT)). CONCLUSION: The Behaviour Change Wheel may be used to improve adherence in clinical trials by identifying barriers to self-management behaviours and guiding development of targeted strategies.

Psychological predictors of vaping uptake among non-smokers: A longitudinal investigation of New Zealand adults.

INTRODUCTION: Demographic and health factors are known to predict vaping. Less is known about psychological predictors of vaping uptake, particularly among non-smoking adults using longitudinal designs. We aimed to model how psychological factors related to personality and mental health predicted the likelihood of vaping uptake over time in non-smoking adults ages 18+ using longitudinal data. METHODS: Longitudinal regression models utilised data from the 2018-2020 waves of the New Zealand Attitudes and Values Study to assess how the Big Five personality traits, mental distress and self-control predicted who began vaping over time among non-users (non-vapers and non-smokers), controlling for gender, age, ethnicity and economic deprivation. RESULTS: Analyses included 36,309 adults overall (ages 18 to 99; M = 51.0). The number of non-users who transitioned into current vaping was small (transitioned from 2018 to 2019, n = 147; 0.48%; 2019 to 2020, n = 189, 0.63%). Fully adjusted models showed that adults with higher mental distress (adjusted odds ratio [aOR] 1.43; 95% confidence interval [CI] 1.09-1.88), lower self-control (aOR 0.79; 95% CI 0.69-0.89) and higher extraversion (aOR 1.09; 95% CI 1.06-1.13) were more likely to begin vaping at the next time point compared to adults who remained non-users. Higher neuroticism and lower conscientiousness also predicted vaping uptake in initial models, but inclusion of mental distress and self-control superseded these traits. DISCUSSION AND CONCLUSIONS: Psychological factors related to mental distress, impulse control and sociability predicted who was more likely to begin vaping as non-smoking adults. Harm prevention interventions could target these factors to reduce vaping uptake in non-smokers.

The association between influenza vaccination uptake and influenza and pneumonia-associated deaths in the United States.

BACKGROUND: The influenza mortality burden has remained substantial in the United States (US) despite relatively high levels of influenza vaccine uptake. This has led to questions regarding the effectiveness of the program against this outcome, particularly in the elderly. The aim of this evaluation was to develop and explore a new approach to estimating the population-level effect of influenza vaccination uptake on pneumonia and influenza (P&I) associated deaths. METHODS: Using publicly available data we examined the association between state-level influenza vaccination and all-age P&I associated deaths in the US from the 2013-2014 influenza season to the 2018-2019 season. In the main model, we evaluated influenza vaccine uptake in all those age 6 months and older. We used a mixed-effects regression analysis with generalised least squares estimation to account for within state correlation in P&I mortality. RESULTS: From 2013-2014 through 2018-2019, the total number of all-age P&I related deaths during the influenza seasons was 480,111. The mean overall cumulative influenza vaccine uptake (age 6 months and older) across the states and years considered was 46.7%, with higher uptake (64.8%) observed in those aged ≥ 65 years. We found that overall influenza vaccine uptake (6 months and older) had a statistically significant protective association with the P&I death rate. This translated to a 0.33 (95% CI: 0.20, 0.47) per 100,000 population reduction in P&I deaths in the influenza season per 1% increase in overall influenza vaccine uptake. DISCUSSION: These results using a population-level statistical approach provide additional support for the overall effectiveness of the US influenza vaccination program. This reassurance is critical given the importance of ensuring confidence in this life saving program. Future research is needed to expand on our approach using more refined data.

Investigation and treatment after non-ST segment elevation acute coronary syndrome for patients presenting to rural or urban hospitals in Aotearoa New Zealand: ANZACS-QI 75.

AIMS: Compare the care patients with non-ST segment elevation acute coronary syndrome (NSTEACS) received in Aotearoa New Zealand depending on the rural-urban category of the hospital they are first admitted to. METHODS: Patients with NSTEACS investigated with invasive coronary angiogram between 1 January 2014 and 31 December 2019 were included. There were three hospital categories (routine access to percutaneous coronary intervention [urban interventional], other urban [urban non-interventional] and rural) and three ethnicity categories (Maori, Pacific and non-Maori/non-Pacific). Clinical performance measures included: angiography ≤3 days, assessment of left ventricular ejection fraction (LVEF) and prescription of secondary prevention medication. RESULTS: Of 26,779 patients, 66.2% presented to urban-interventional, 25.6% to urban non-interventional and 8.2% to rural hospitals. A smaller percentage of patients presenting to urban interventional than urban non-interventional and rural hospitals were Maori (8.1%, 17.0% and 13.0%). Patients presenting to urban interventional hospitals were more likely to receive timely angiography than urban non-interventional or rural hospitals (78.5%, 60.8% and 63.1%). They were also more likely to have a LVEF assessment (78.5%, 65.4% and 66.3%). In contrast, the use of secondary prevention medications at discharge was similar between hospital categories. Maori and Pacific patients presenting to urban interventional hospitals were less likely than non-Maori/non-Pacific to receive timely angiography but more likely to have LVEF assessed. However, LVEF assessment and timely angiography in urban non-interventional and rural hospitals were lower than in urban interventional hospitals for both Maori and non-Maori/non-Pacific. CONCLUSIONS: Patients presenting to urban hospitals without routine interventional access and rural hospitals were less likely to receive LVEF assessment or timely angiography. This disproportionately impacts Maori, who are more likely to live in these hospital catchments.

Outcomes and access to angiography following non-ST-segment elevation acute coronary syndromes in patients who present to rural or urban hospitals: ANZACS-QI 72.

AIM: This study's aim was to identify differences in invasive angiography performed and health outcomes for patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) presenting to either i) a rural hospital, or an urban hospital ii) with or iii) without routine access to percutaneous intervention (PCI) in New Zealand. METHODS: Patients with NSTEACS between 1 January 2014 and 31 December 2017 were included. Logistic regression was used to model each of the outcome measures: angiography performed within 1 year; 30-day, 1-year and 2-year all-cause mortality; and readmission within 1 year of presentation with either heart failure, a major adverse cardiac event or major bleeding. RESULTS: There were 42,923 patients included. Compared to urban hospitals with access to PCI, the odds of a patient receiving an angiogram were reduced for rural and urban hospitals without routine access to PCI (odds ratio [OR] 0.82 and 0.75) respectively. There was a small increase in the odds of dying at 2 years (OR 1.16), but not 30 days or 1 year for patients presenting to a rural hospital. CONCLUSION: Patients who present to hospitals without PCI are less likely to receive angiography. Reassuringly there is no difference in mortality, except at 2 years, for patients that present to rural hospitals.

Strategies to Improve Adherence to Skin Self-examination and Other Self-management Practices in People at High Risk of Melanoma: A Scoping Review of Randomized Clinical Trials.

Importance: Adherence, both in research trials and in clinical practice, is crucial to the success of interventions. There is limited guidance on strategies to increase adherence and the measurement and reporting of adherence in trials of melanoma self-management practices. Objective: This scoping review aimed to describe (1) strategies to improve adherence to self-management practices in randomized clinical trials of people at high risk of melanoma and (2) measurement and reporting of adherence data in these trials. Evidence Review: Four databases, including MEDLINE, Embase, CENTRAL, and CINAHL, were searched from inception to July 2022. Eligible studies were randomized clinical trials of self-monitoring interventions for early detection of melanoma in people at increased risk due to personal history (eg, melanoma, transplant, dysplastic naevus syndrome), family history of melanoma, or as determined by a risk assessment tool or clinical judgment. Findings: From 939 records screened, 18 eligible randomized clinical trials were identified, ranging in size from 40 to 724 participants, using a range of adherence strategies but with sparse evidence on effectiveness of the strategies. Strategies were classified as trial design (n = 15); social and economic support (n = 5); intervention design (n = 18); intervention and condition support (n = 10); and participant support (n = 18). No strategies were reported for supporting underserved groups (eg, people who are socioeconomically disadvantaged, have low health literacy, non-English speakers, or older adults) to adhere to self-monitoring practices, and few trials targeted provider (referring to both clinicians and researchers) adherence (n = 5). Behavioral support tools included reminders (n = 8), priority-setting guidance (n = 5), and clinician feedback (n = 5). Measurement of adherence was usually by participant report of skin self-examination practice with some recent trials of digital interventions also directly measuring adherence to the intervention through website or application analytic data. Reporting of adherence data was limited, and fewer than half of all reports mentioned adherence in their discussion. Conclusions and Relevance: Using an adaptation of the World Health Organization framework for clinical adherence, this scoping review of randomized clinical trials identified key concepts as well as gaps in the way adherence is approached in design, conduct, and reporting of trials for skin self-examination and other self-management practices in people at high risk of melanoma. These findings may usefully guide future trials and clinical practice; evaluation of adherence strategies may be possible using a Study Within A Trial (SWAT) framework within host trials.

Describing the health-related quality of life of Maori adults in Aotearoa me Te Waipounamu (New Zealand).

PURPOSE: In Aotearoa me Te Waipounamu (New Zealand; NZ) there are considerable inequities in health status and outcomes for Maori, the Indigenous peoples of NZ. It is therefore important that the health status and preferences of Maori are specifically considered in healthcare policy and decision making. This paper describes the health-related quality of life of 390 Maori adults who took part in the NZ EQ-5D-5L valuation study. METHODS: Responses on the five dimensions of the EQ-5D-5L were dichotomised into "no problems" and "any problems", summarised and disaggregated by age group. Mean preference weights were reported by age group and overall. Mean utility values (calculated by applying each participant's preference weights to their EQ-5D-5L profile) were summed and respective means and standard deviations reported by age, chronic disease status and disability. RESULTS: The EQ-5D-5L dimensions with the highest proportion of participants reporting any problems were pain/discomfort (61.5%) and anxiety/depression (50%). The most commonly-reported chronic disease was mental illness/distress (24.6%). Anxiety/depression ranked as the most important dimension, with usual activities, the least important. The mean utility value was 0.83 with the lowest value (0.79) found in the 18-24 and 45-54 age groups. For participants with at least one chronic disease the mean utility value was 0.76 compared to 0.91 for those with none. CONCLUSION: To reduce inequities experienced by Maori it is crucial that the health status of Maori and the values Maori place on health-related quality of life are properly understood. This can only be achieved using Maori-specific data.

Players', parents' and staffs' perceptions of injury prevention exercise programmes in youth rugby union.

Background and aim: Despite evidence of their efficacy, there is no widespread adoption of injury prevention exercise programmes (IPEPs) among young players and coaches in community rugby union. The purpose of this study was to (1) analyse the knowledge and perceptions of injury prevention and IPEPs among staff, parents and players in youth rugby union and (2) explore the facilitators and barriers to implementation of IPEPs. With this contextual information, tailored implementation strategies can be created. Methods: Participants completed an online survey addressing knowledge and perceptions of injury risk, injury prevention practices and a rugby-specific IPEP. Community rugby union players aged 14-18 years, their parents and staff were invited to participate, including school-based and development squads competing at a national level. Results: Surveys were completed by 18 staff members, 72 parents and 56 players. Staff, parents and players believe that the risk of injury in youth rugby union is high and that injury prevention is important. The perceived role in injury prevention and availability of allied health staff, particularly strength and conditioning coaches, was apparent in this sample. Reported barriers to completion of IPEPs related to time, resources, awareness of the programme and end-users' attitudes or motivations. Leadership, the use of role models and the structure and routine provided by an IPEP were considered facilitative. Conclusions: These findings inform future implementation strategies for IPEPs in this setting, including the need to provide practical solutions, education and considering the role of allied health staff in facilitating such programmes.

Modelled estimates of hospitalisations attributable to respiratory syncytial virus and influenza in Australia, 2009-2017.

BACKGROUND: Respiratory syncytial virus (RSV) and influenza are important causes of disease in children and adults. In Australia, information on the burden of RSV in adults is particularly limited. METHODS: We used time series analysis to estimate respiratory, acute respiratory infection, pneumonia and influenza, and bronchiolitis hospitalisations attributable to RSV and influenza in Australia during 2009 through 2017. RSV and influenza-coded hospitalisations in <5-year-olds were used as proxies for relative weekly viral activity. RESULTS: From 2009 to 2017, the estimated all-age average annual rates of respiratory hospitalisations attributable to RSV and seasonal influenza (excluding 2009) were 54.8 (95% confidence interval [CI]: 20.1, 88.8) and 87.8 (95% CI: 74.5, 97.7) per 100,000, respectively. The highest estimated average annual RSV-attributable respiratory hospitalisation rate per 100,000 was 464.2 (95% CI: 285.9, 641.2) in <5-year-olds. For seasonal influenza, it was 521.6 (95% CI: 420.9, 600.0) in persons aged ≥75 years. In ≥75-year-olds, modelled estimates were approximately eight and two times the coded estimates for RSV and seasonal influenza, respectively. CONCLUSIONS: RSV and influenza are major causes of hospitalisation in young children and older adults in Australia, with morbidity underestimated by hospital diagnosis codes.

TWIN-10: protocol for a 10-year longitudinal twin study of the neuroscience of mental well-being and resilience.

INTRODUCTION: Mental well-being is a core component of mental health, and resilience is a key process of positive adaptive recovery following adversity. However, we lack an understanding of the neural mechanisms that contribute to individual variation in the trajectories of well-being and resilience relative to risk. Genetic and/or environmental factors may also modulate these mechanisms. The aim of the TWIN-10 Study is to characterise the trajectories of well-being and resilience over 12 years across four timepoints (baseline, 1 year, 10 years, 12 years) in 1669 Australian adult twins of European ancestry (to account for genetic stratification effects). To this end, we integrate data across genetics, environment, psychological self-report, neurocognitive performance and brain function measures of well-being and resilience. METHODS AND ANALYSIS: Twins who took part in the baseline TWIN-E Study will be invited back to participate in the TWIN-10 Study, at 10-year and 12-year follow-up timepoints. Participants will complete an online battery of psychological self-reports, computerised behavioural assessments of neurocognitive functions and MRI testing of the brain structure and function during resting and task-evoked scans. These measures will be used as predictors of the risk versus resilience trajectory groups defined by their changing levels of well-being and illness symptoms over time as a function of trauma exposure. Structural equation models will be used to examine the association between the predictors and trajectory groups of resilience and risk over time. Univariate and multivariate twin modelling will be used to determine heritability of the measures, as well as the shared versus unique genetic and environmental contributions. ETHICS AND DISSEMINATION: This study involves human participants. This study was approved by the University of New South Wales Human Research Ethics Committee (HC180403) and the Scientific Management Panel of Neuroscience Research Australia Imaging (CX2019-05). Results will be disseminated through publications and presentations to the public and the academic community. Participants gave informed consent to participate in the study before taking part.

What is the effect of a low literacy talking book on patient knowledge, anxiety and communication before radiation therapy starts? A pilot study.

INTRODUCTION: Radiation therapy is a common cancer treatment, requiring timely information to help patients prepare for treatment. We pilot tested a low literacy, psycho-educational talking book (written booklet, with accompanying audio recording) to examine (i) the effect of the tool on knowledge, anxiety and communication; (ii) acceptability, and (iii) how it was used in appointments. METHODS: A pre-post design was employed. Patients scheduled to receive radiation therapy for any cancer were recruited from two hospitals in Sydney, Australia. Participants were sent the talking book before treatment planning and completed baseline and follow-up surveys, before and after the intervention. RESULTS: Forty participants were recruited, and 39 completed all study assessments. Overall, knowledge increased after receiving the talking book by 3.8 points from 13.9 to 17.7/20 (95% confidence interval (CI) 2.7, 4.8, P < 0.001). Anxiety and concerns were significantly lower after receiving the talking book (P = 0.015 and P = 0.004, respectively). Nearly half of participants (s = 17, 48%) reported using the book during appointments. Most reported finding it easier to communicate (n = 31, 89%) and to ask more questions (n = 21, 62%). CONCLUSION: The talking book shows promise in improving knowledge, reducing anxiety and enhancing communication. Strategies to support the implementation of the talking book are required. Further studies to translate the book into different languages are also planned.

A retrospective analysis of magnetic resonance cholangiopancreatography investigating gallstones in a contemporary surgical setting.

BACKGROUNDS: The New Zealand Public Health System operates in a resource limited environment. Pre-operative investigation of choledocholithiasis (CDL) is variable. Protocol driven practice has improved patient outcomes and cost-effectiveness. The aim is to explore risk stratification for CDL and specific thresholds for accessing magnetic resonance cholangiopancreatography (MRCP) in this contemporary setting. METHODS: All adult (16+ years) acute inpatient MRCP requests for gallstone work-up between 1 Jan 2018 and 2031 Dec 2019 at Dunedin Hospital were included. Patients with characteristics not in fitting with an acute symptomatic examination were excluded. Receiver operating characteristic curves were estimated for bilirubin versus MRCP positive by the presence/absence of dilated ducts, indication and American Society of Gastrointestinal Endoscopy (ASGE) risk grouping. RESULTS: A 106 patients were included. Mean bilirubin at presentation and time of MRCP, 47 versus 28 µmol/L, respectively. MRCP confirmed CDL in 39 (37%) patients. 38 (97%) had biochemical changes with choledocholithiasis. 21 (40%) with CBD dilation had ductal stones versus 18 (34%) with normal ducts. ASGE risk stratification showed 36 (34%), 66 (62%) and 4 (4%) were high, intermediate and low risk, respectively. Of these groups 44%, 35% and 0% had CBD stones on MRCP, respectively. Combination thresholds involving duct size and bilirubin can yield negative predictive values >90%, substantially reducing MRCP load. CONCLUSIONS: MRCP requests can be triaged to maximize stones detected without overly increasing the rate of missed duct stones whilst protecting the limited MRI and ERCP resources. International thresholds and risk stratification alone may not be applicable in our resource limited environment.

The role of intra-operative void score during transurethral resection of prostate as a marker of efficacy: a feasibility study.

BACKGROUND: To assess the feasibility of a novel intra-operative void scoring technique. To determine if intra-operative void score (VS) could act as a marker for post-operative success following TURP. METHODS: Fifteen patients undergoing TURP were included in this single-centre feasibility study. All patients had indwelling urinary catheters for recurrent retention due to benign prostatic hyperplasia (BPH). In theatre, immediately before- and after TURP, an intra-operative VS was measured and graded 0-5. Primary outcomes were the feasibility of measuring intra-operative VS and its accuracy in predicting surgical outcome. RESULTS: A combined pre- and post-score with a threshold ≥6 correctly predicted 82% of those who were catheter free (sensitivity) and 100% of those who were not catheter free (specificity) at follow up and the positive predictive value was 100% and negative predictive value 60%. CONCLUSION: Intra-operative void score during TURP is simple, reproducible, fast and requires minimal resources. In TURP it may predict successful outcomes by identifying patients who will be catheter free post-operatively as opposed to those who will be catheter dependent despite the procedure.

A prospective multi-centre study assessing the safety and effectiveness following the implementation of an accelerated chest pain pathway using point-of-care troponin for use in New Zealand rural hospital and primary care settings.

AIMS: Most rural hospitals and general practices in New Zealand (NZ) are reliant on point-of-care troponin. A rural accelerated chest pain pathway (RACPP), combining an electrocardiogram (ECG), a structured risk score (Emergency Department Assessment of Chest Pain Score), and serial point-of-care troponin, was designed for use in rural hospital and primary care settings across NZ. The aim of this study was to evaluate the safety and effectiveness of the RACPP. METHODS AND RESULTS: A prospective multi-centre evaluation following implementation of the RACPP was undertaken from 1 July 2018 to 31 December 2020 in rural hospitals, rural and urban general practices, and urgent care clinics. The primary outcome measure was the presence of 30-day major adverse cardiac events (MACEs) in low-risk patients. The secondary outcome was the percentage of patients classified as low-risk that avoided transfer or were eligible for early discharge. There were 1205 patients enrolled in the study. 132 patients were excluded. Of the 1073 patients included in the primary analysis, 474 (44.0%) patients were identified as low-risk. There were no [95% confidence interval (CI): 0-0.3%] MACE within 30 days of the presentation among low-risk patients. Most of these patients (91.8%) were discharged without admission to hospital. Almost all patients who presented to general practice (99%) and urgent care clinics (97.6%) were discharged to home directly. CONCLUSION: The RACPP is safe and effective at excluding MACEs in NZ rural hospital and primary care settings, where it can identify a group of low-risk patients who can be safely discharged home without transfer to hospital.

Creating opportunities to improve detection of older adult abuse: a national interRAI study.

Despite being recognized as a major global health issue, older adult abuse (OAA) remains largely undetected and under-reported. Most OAA assessment tools fail to capture true prevalence. Follow up of patients where abuse exposure is not easily determined is a necessity. The interRAI-HC (International Resident Assessment Instrument-Home Care) currently underestimates the extent of abuse. We investigated how to improve detection of OAA using the interRAI-HC. Analysis of 7 years of interRAI-HC data from an Aotearoa New Zealand cohort was completed. We identified that through altering the criteria for suspicion of OAA, capture rates of at-risk individuals could be nearly doubled from 2.6% to 4.8%. We propose that via adapting the interRAI-HC criteria to include the "unable to determine" whether abuse occurred (UDA) category, identification of OAA sufferers could be substantially improved. Improved identification will facilitate enhanced protection of this vulnerable population.

Cost-Effectiveness of PET/CT Surveillance Schedules to Detect Distant Recurrence of Resected Stage III Melanoma.

OBJECTIVE: To estimate the cost-effectiveness of three surveillance imaging strategies using whole-body positron emission tomography (PET) with computed tomography (CT) (PET/CT) in a follow-up program for adults with resected stage III melanoma. METHODS: An analytic decision model was constructed to estimate the costs and benefits of PET/CT surveillance imaging performed 3-monthly, 6-monthly, or 12-monthly compared with no surveillance imaging. RESULTS: At 5 years, 3-monthly PET/CT surveillance imaging incurred a total cost of AUD 88,387 per patient, versus AUD 77,998 for 6-monthly, AUD 52,560 for 12-monthly imaging, and AUD 51,149 for no surveillance imaging. When compared with no surveillance imaging, 12-monthly PET/CT imaging was associated with a 4% increase in correctly diagnosed and treated distant disease; a 0.5% increase with 6-monthly imaging and 1% increase with 3-monthly imaging. The incremental cost-effectiveness ratio (ICER) of 12-monthly PET/CT surveillance imaging was AUD 34,362 for each additional distant recurrence correctly diagnosed and treated, compared with no surveillance imaging. For the outcome of cost per diagnostic error avoided, the no surveillance imaging strategy was the least costly and most effective. CONCLUSION: With the ICER for this strategy less than AUD 50,000 per unit of health benefit, the 12-monthly surveillance imaging strategy is considered good value for money.

The Impact of Surveillance Imaging Frequency on the Detection of Distant Disease for Patients with Resected Stage III Melanoma.

BACKGROUND: It is not known whether there is a survival benefit associated with more frequent surveillance imaging in patients with resected American Joint Committee on Cancer stage III melanoma. OBJECTIVE: The aim of this study was to investigate distant disease-free survival (DDFS), melanoma-specific survival (MSS), post distant recurrence MSS (dMSS), and overall survival for patients with resected stage III melanoma undergoing regular computed tomography (CT) or positron emission tomography (PET)/CT surveillance imaging at different intervals. PATIENTS AND METHODS: A closely followed longitudinal cohort of patients with resected stage IIIA-D disease treated at a tertiary referral center underwent 3- to 4-monthly, 6-monthly, or 12-monthly surveillance imaging between 2000 and 2017. Survival outcomes were estimated using the Kaplan-Meier method, and log-rank tests assessed the significance of survival differences between imaging frequency groups. RESULTS: Of 473 patients (IIIA, 19%; IIIB, 31%; IIIC, 49%; IIID, 1%) 30% underwent 3- to 4-monthly imaging, 10% underwent 6-monthly imaging, and 60% underwent 12-monthly imaging. After a median follow-up of 6.2 years, distant recurrence was recorded in 252 patients (53%), with 40% detected by surveillance CT or PET/CT, 43% detected clinically, and 17% with another imaging modality. Median DDFS was 5.1 years (95% confidence interval 3.9-6.6). Among 139 IIIC patients who developed distant disease, the median dMSS was 4.4 months shorter in those who underwent 3- to 4-monthly imaging than those who underwent 12-monthly imaging. CONCLUSION: Selecting patients at higher risk of distant recurrence for more frequent surveillance imaging yields a higher proportion of imaging-detected distant recurrences but is not associated with improved survival. A randomized comparison of low versus high frequency imaging is needed.

The prevalence of chronic kidney disease in Samoans living in Auckland, New Zealand.

AIMS: Pacific peoples have higher rates of chronic kidney disease (CKD) and are five times more likely to commence kidney replacement therapy compared with New Zealand (NZ) Europeans. As the majority live Auckland, this study looked at the prevalence of CKD in two Auckland Pacific Island health providers caring for a large proportion of Pacific peoples, of which almost 50% are Samoan, as well as NZ Europeans. METHODS: De-identified information was requested on individuals who had two or more CKD tests (serum creatinine and urinary albumin creatinine ratios) more than 3 months apart. CKD prevalence across different demographic groups was determined. Logistic regression was used to look at associations of known risk factors and CKD. RESULTS: Data from 25 127 patients was evaluated. Of the total sample, 7451 individuals identified as Samoans. The prevalence of CKD amongst all Samoans in this sample was 17.8% increasing to 36.3% in those Samoans that had been tested for CKD. The prevalence of CKD in this total sample was 13% increasing to 27.5% considering only those who had CKD testing. The odds of Samoans having CKD (adjOR: 1.9 [95%CI 1.7, 2.2]), all other Pacific Island ethnicities identified and NZ Maori (adjOR:1.5 [95%CI 1.3, 1.8]), were increased compared with non-Maori-non-Pacific (likelihood p value <.001). CONCLUSION: We report the high prevalence of CKD (15.9%-33.4%) in Samoans living in New Zealand. This reveals an urgent need for further studies to develop strategies to prevent or reduce the development of kidney failure and premature death.

Assessing the Potential for Patient-led Surveillance After Treatment of Localized Melanoma (MEL-SELF): A Pilot Randomized Clinical Trial.

IMPORTANCE: Patient-led surveillance is a promising new model of follow-up care following excision of localized melanoma. OBJECTIVE: To determine whether patient-led surveillance in patients with prior localized primary cutaneous melanoma is as safe, feasible, and acceptable as clinician-led surveillance. DESIGN, SETTING, AND PARTICIPANTS: This was a pilot for a randomized clinical trial at 2 specialist-led clinics in metropolitan Sydney, Australia, and a primary care skin cancer clinic managed by general practitioners in metropolitan Newcastle, Australia. The participants were 100 patients who had been treated for localized melanoma, owned a smartphone, had a partner to assist with skin self-examination (SSE), and had been routinely attending scheduled follow-up visits. The study was conducted from November 1, 2018, to January 17, 2020, with analysis performed from September 1, 2020, to November 15, 2020. INTERVENTION: Participants were randomized (1:1) to 6 months of patient-led surveillance (the intervention comprised usual care plus reminders to perform SSE, patient-performed dermoscopy, teledermatologist assessment, and fast-tracked unscheduled clinic visits) or clinician-led surveillance (the control was usual care). MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of eligible and contacted patients who were randomized. Secondary outcomes included patient-reported outcomes (eg, SSE knowledge, attitudes, and practices, psychological outcomes, other health care use) and clinical outcomes (eg, clinic visits, skin surgeries, subsequent new primary or recurrent melanoma). RESULTS: Of 326 patients who were eligible and contacted, 100 (31%) patients (mean [SD] age, 58.7 [12.0] years; 53 [53%] men) were randomized to patient-led (n = 49) or clinician-led (n = 51) surveillance. Data were available on patient-reported outcomes for 66 participants and on clinical outcomes for 100 participants. Compared with clinician-led surveillance, patient-led surveillance was associated with increased SSE frequency (odds ratio [OR], 3.5; 95% CI, 0.9 to 14.0) and thoroughness (OR, 2.2; 95% CI, 0.8 to 5.7), had no detectable adverse effect on psychological outcomes (fear of cancer recurrence subscale score; mean difference, -1.3; 95% CI, -3.1 to 0.5), and increased clinic visits (risk ratio [RR], 1.5; 95% CI, 1.1 to 2.1), skin lesion excisions (RR, 1.1; 95% CI, 0.6 to 2.0), and subsequent melanoma diagnoses and subsequent melanoma diagnoses (risk difference, 10%; 95% CI, -2% to 23%). New primary melanomas and 1 local recurrence were diagnosed in 8 (16%) of the participants in the intervention group, including 5 (10%) ahead of routinely scheduled visits; and in 3 (6%) of the participants in the control group, with none (0%) ahead of routinely scheduled visits (risk difference, 10%; 95% CI, 2% to 19%). CONCLUSIONS AND RELEVANCE: This pilot of a randomized clinical trial found that patient-led surveillance after treatment of localized melanoma appears to be safe, feasible, and acceptable. Experiences from this pilot study have prompted improvements to the trial processes for the larger trial of the same intervention. TRIAL REGISTRATION: http://anzctr.org.au Identifier: ACTRN12616001716459.